Trial Outcomes & Findings for T-wave Alternans and Intrathoracic Impedance Measurements (NCT NCT00669682)

Results Overview

We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

upto 3 years

Results posted on

2013-04-19

Participant Flow

9 patients enrolled from device clinic between 8/14/08 and 2/11/11

Participant milestones

Participant milestones
Measure	Group A The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T-wave Alternans and Intrathoracic Impedance Measurements

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=9 Participants The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: upto 3 years

We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.

Outcome measures

Outcome measures
Measure	Positive Optivol Status n=3 Participants These patients have transthoracic impedance measurements that suggest fluid overload	Negative Optivol Status n=6 Participants These patients have transthoracic impedance measurements that do not suggest fluid overload
Number of Positive Twave Studies and Concurrent Positive Optivol Measurement Negative T wave alternans	2 participants	5 participants
Number of Positive Twave Studies and Concurrent Positive Optivol Measurement Positive T wave alternans	1 participants	1 participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose' Dizon, MD

Columbia University

Phone: 212-305-8559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place